Recall Alert: TRUE METRIX® Blood Glucose Meters

Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging

Trividia Health, Inc. has initiated a labeling correction affecting all TRUE METRIX®, TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO® blood glucose monitoring systems distributed in the United States, United Kingdom, Mexico, Australia, and the Caribbean.

The action modifies the Owner’s Booklets/System Instructions for Use (IFU) to clarify and emphasize that users must seek immediate medical attention if they receive an E-5 error code and are experiencing symptoms of hyperglycemia.

Importantly, this is a labeling correction, not a device removal or replacement. Products remain in distribution and may continue to be used.

What Triggered the Correction?

The E-5 error code is displayed when a very high blood glucose result is detected (>600 mg/dL), or a test strip error occurs.

As previously written, the IFU did not sufficiently emphasize the urgency of seeking medical care if the user was symptomatic. The concern is that users might retest without recognizing the potential severity of a hyperglycemic crisis.

A delay in treatment of very high blood glucose can result in serious adverse health consequences, including diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), or death.

Since the product’s global launch in August 2014, there have been 114 reported serious injuries and one reported death associated with the E-5 error code scenario.

While causation is not explicitly stated, the risk profile was sufficient to warrant corrective action.

What Is Changing?

The updated instructions now prominently include a “WARNING!!” statement:

If an E-5 error persists and the user has symptoms such as fatigue, excess urination, thirst, or blurry vision, they must seek medical attention immediately.

If no symptoms are present, users are instructed to retest with a new strip and contact customer support if the error persists.

The correction applies to the printed Owner’s Booklets packaged with meters, online labeling, help guides, and co-branded versions distributed through retail partners.

Pharmacies, distributors, and mail-order companies are being instructed to post and forward the Product Notice.

Regulatory Classification: Why This Matters

This action is classified as a labeling correction, not a recall requiring removal from market.

Under FDA recall classifications, labeling corrections often fall into Class II or sometimes Class I territory depending on risk severity. Although the FDA classification has not yet been publicly assigned, the inclusion of “serious adverse health consequences or death” language indicates the hazard assessment was significant.

This case reinforces several key regulatory principles:

Error Codes Are Risk Controls

Error messaging in medical devices is not merely technical feedback; it is a risk mitigation control under ISO 14971 risk management frameworks.

If an error code can represent both a benign condition (test strip error), and a life-threatening condition (>600 mg/dL), then labeling clarity becomes a primary safeguard.

Human Factors Engineering Is Critical

Clear escalation instructions are a human factors issue. When patients manage chronic conditions, ambiguity in instructions can create delay behaviors that amplify risk.

Post-Market Surveillance Drives Labeling Evolution

The fact that the device has been on the market since 2014 demonstrates how post-market complaint trending can identify labeling insufficiencies years after launch.

Broader Implications for Manufacturers

Manufacturers of patient-operated diagnostic devices should review error code decision trees, escalation language in IFUs, symptom cross-references, alignment between device firmware messaging and labeling, and risk control effectiveness verification under real-world use conditions.

Where error codes can indicate both benign and severe conditions, instructions must remove ambiguity. And a “retest first” instruction without clear symptom triage language can create unintended delay.

What Users Should Do

Trividia Health advises users to continue using TRUE METRIX products, and no return or replacement is required. Users should also review updated E-5 instructions and seek medical attention immediately if experiencing symptoms and an E-5 error persists.

Users may contact Trividia Customer Care (+1-888-835-2723), visit the company’s product notice webpage, and report adverse events to FDA MedWatch.

MDP Perspective

This case illustrates a recurring theme in medical device regulation, that device performance is only as safe as the clarity of its instructions.

Labeling is not just an accessory to safety; it is a core risk control mechanism. And when error messages intersect with potentially life-threatening conditions, the standard for clarity must be exceptionally high.

Manufacturers should view this not simply as a corrective labeling update, but as a reminder to continuously evaluate whether instructions are sufficiently explicit to prevent delay in care.

Read the company announcement here.